Definition: For The Replacement Of Diseased, Damaged, Malformed Or Malfunctioning Native Or Prosthetic Pulmonary Heart Valves. They May Also Be Used In The Replacement Of Native Pulmonary Heart Valves When The Ross Procedure Is Performed. Pulmonary Heart Valve A
| Device Type ID | 1068 |
| Device Name | Heart Valve, More Than Minimally Manipulated Allograft |
| Physical State | The Allograft Heart Valve Has Been More Than Minimally Manipulated. |
| Technical Method | The Allograft Heart Valve Replaces The Native Or Prosthetic Pulmonary Heart Valve. |
| Target Area | Pulmonary Heart Valve |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OHA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1068 |
| Device | Heart Valve, More Than Minimally Manipulated Allograft |
| Product Code | OHA |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Appropriate Term/Code Not Available | 2 |
Crack | 2 |
Torn Material | 1 |
Insufficient Information | 1 |
| Total Device Problems | 14 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CryoLife, Inc. | II | Jun-21-2018 |